New, Improved and Generic Devices: Japanese Predicate Comparison and Timelines

1. Key takeaways

Japan positions a product, by its relationship to predicate items already on the Japanese market, into one of three categories: new medical devices, improved medical devices and generic medical devices. The positioning directly determines the clinical evidence required and the PMDA processing-period target. GRZAN’s reminder: positioning is not a label the applicant chooses freely; it is derived by comparison with Japanese approved items on structural principle, intended use and performance.

• Article 23-2-5(2) of the PMD Act, the review-judgment provision for approval, is the legal source of the clinical evidence requirements.
• MHLW notification Yakushokuhatsu No. 0806-3 of 6 August 2014 prescribes the application form and attached data for approval applications.
• PMDA’s Profile of Services states the new-device review target of 14 months and the priority review target of 10 months.
• PMDA performance data (FY2019 to FY2023, 80th percentile) show standard review at 11.4 months and priority review at 8.7 months in FY2023.
• GRZAN’s assessment: comparisons built on an FDA predicate, rather than a Japanese predicate, are among the most frequent causes of returns in Japanese review.
• The positioning decision also shapes the consultation strategy, because PMDA’s questions about evidence depth follow directly from whether the item is argued as new, improved or generic.

2. Legal basis

Review-judgment requirements. Article 23-2-5(2) of the PMD Act sets the review-judgment requirements for approval and forms the legal basis on which the depth of clinical evidence is demanded.

Implementation notification. The notification of the Director of the Pharmaceutical and Food Safety Bureau on the enforcement of the partially revised PMD Act and related laws, Yakushokuhatsu No. 0806-3 of 6 August 2014, prescribes the form of the approval application and the attached documents for medical devices.

Processing-period targets. PMDA’s Profile of Services states the review processing-period targets: 14 months for new medical devices and 10 months for priority review. These are institution-set efficiency targets, not commitments.

Performance data. PMDA discloses actual performance at the 80th percentile. For FY2019 to FY2023, standard review ranged from 10.8 to 12.0 months and stood at 11.4 months in FY2023; priority review ranged from 7.3 to 8.9 months and stood at 8.7 months in FY2023.

Current legal corpus. Act No. 145 of 1960 (the PMD Act).

Practical estimate: schedule standard review at the top of the performance range, around a 12-month magnitude, and priority review at around 9 months, keeping applicant response time outside the review clock.

3. Expert insights

The comparison object must be a Japanese predicate item. The distinction between new, improved and generic asks whether a comparable item already exists on the Japanese market. A predicate cleared through a US 510(k) cannot substitute for this comparison. Building the generic argument directly on the FDA predicate is among the most frequent reasons applications are returned in Japanese review. GRZAN requires a written comparison table against Japanese approved items, with fields for structural principle, intended use, performance indicators and the intended subject population, before any positioning statement is drafted.

The 14-month target is a processing-period target, not a promise. PMDA’s published target is a self-set efficiency indicator, and actual results are disclosed at the 80th percentile. Across FY2019 to FY2023, standard review results moved within a range of 10.8 to 12.0 months and priority review results within 7.3 to 8.9 months. Scheduling the project at the upper edge of the performance range is closer to reality than scheduling against the target value. A plan built on 14 months for standard review can be safe in most years, while treating the 10-month priority figure as a commitment invites slip. The distinction also disciplines internal reporting: project managers should communicate both numbers to management, the target as an aspiration and the percentile range as the planning basis, so that downstream launch decisions are never anchored on the weaker number.

Positioning affects not only the timeline but who runs the QMS investigation. For new medical devices and Class IV items, the QMS conformity investigation is conducted by PMDA; for Class II and Class III items with certification standards, it is conducted by the RCB. Positioning and pathway together determine the investigating body, and the investigating body determines scheduling behaviour. Confirming both early prevents a late surprise in which the review plan and the investigation plan were built for different institutions. It also prevents double work: the QMS documentation set differs in emphasis depending on whether PMDA or the RCB investigates, and assembling it before the investigating body is known risks rework at the worst possible moment, immediately before filing.

4. Practical recommendations

• Build the comparison table against Japanese approved items only, with fields for structural principle, intended use, performance indicators and intended subjects.
• Schedule at the upper edge of the performance range: reserve around 12 months for standard review and around 9 months for priority review.
• When positioning is uncertain, use PMDA consultation before submission. Positioning drives the scale of clinical evidence, and early determination avoids post-submission additional studies.
• Keep applicant preparation time outside the processing period. PMDA’s disclosed statistics generally exclude time consumed by applicant responses, so corporate preparation and reply time must be scheduled separately.
• Confirm whether PMDA or the RCB runs the QMS conformity investigation as soon as positioning and pathway are set.

5. Verification checklist

• □ Is the comparison object a Japanese approved item, not an FDA or CE predicate?
• □ Has the written comparison been completed across structural principle, intended use and performance indicators?
• □ Is the project schedule built on the upper edge of PMDA’s performance range rather than the target value?
• □ Has the body conducting the QMS conformity investigation (PMDA or RCB) been confirmed from the positioning and pathway?
• □ Is applicant response time scheduled separately and not mixed into the review processing period?

Regulatory information verified as at 29 October 2026. Legal texts follow the current provisions published on e-Gov and the notices issued by MHLW and PMDA, and must be rechecked after amendment or repeal. Time limits and procedural details reflect the official position on that date; content marked practical estimate has no legal effect.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, in-country representative and local testing support for the Japanese market. Our team manages PMDA premarket submissions and notification procedures, coordinates clinical evidence, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com